Safety and Efficacy of "Standardized" CHIP

Safety and Efficacy of "Standardized" Complex High-risk Interventional Procedures - a New Pathway for Protected Percutaneous Coronary Interventions

In routine clinical practice, high-risk patients with high-risk anatomies are more often referred for interventional treatment by percutaneous coronary interventions (PCI). Current guidelines only suggest that elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in selected high-risk patients.

The objective of this study is to investigate the safety and efficacy of a "standardized program" for complex high-risk interventional procedures (CHIP).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: percutaneous coronary interventions

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45122
      • University Hospital Essen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population consists of consecutive high-risk subjects indicated for percutaneous complex high-risk interventional procedures.

Description

Inclusion Criteria:

• Signed Informed Consent
• Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft

Exclusion Criteria:

• Subject has uncorrectable abnormal coagulation parameters (defined as platelet count ≤75,000/mm3 or INR ≥2.5.)
• History of recent (within 1 month) stroke or TIA
• Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CHIP 1 - low risk patients	Other: percutaneous coronary interventions; Percutaneous coronary intervention.
CHIP 2 - medium risk patients	Other: percutaneous coronary interventions; Percutaneous coronary intervention.
CHIP 3 - high risk patients	Other: percutaneous coronary interventions; Percutaneous coronary intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety & feasibility	Accurate classification of patients into the respective group defined by the necessity of upgrade	30 days
Hemodynamic Compromise (HC)	Freedom from hemodynamic compromise during PCI procedure defined as: mean arterial pressure (MAP) not decreasing to values below 60 mmHg for more than 10 minutes during the PCI procedure	30 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac and Cerebrovascular Events (MACCE)	A composite rate of the following intra-procedural and post-procedural Major Adverse Cardiac and Cerebrovascular Events (MACCE) events defined as death, new myocardial infarction, or cerebrovascular accident up to 30 days post index procedure.	30 days
Adverse events	Rates of acute kidney injury ([AKI] according to KDIGO), sepsis, vascular complications (defined by Valve Academic Research Consortium 2 [VARC 2]), bleeding (defined by Bleeding Academic Research Consortium [BARC]) and coronary complications.	30 days

Collaborators and Investigators

• Sponsor: University Hospital, Essen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: FA_2017_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No